ISO/WD 25289

Biotechnology — Key components and minimum requirements for the model of bronchial microphysiological systems

Scope

This document describes performance metrics, acceptance criteria, and evaluation methods for bronchial microphysiological systems (MPS) using air-liquid interface (ALI) culture. It is performance-based and technology-agnostic and does not prescribe or standardize specific device architectures, materials, or fabrication methods beyond reporting requirements and context-of-use justification. This document primarily applies to models based on human cells, but does not cover application-specific study designs. This document provides performance-based guidance for airway MPS/OoC with microfluidic control using ALI, where dynamic microenvironmental parameters (e.g., flow/shear, cyclic strain) and multi-compartment architectures with integrated sensing introduce additional sources of variability.